Agency Denies Industry Petition and Publishes Revised Draft Guidance
The U.S. Food and Drug Administration (FDA) appears set to ramp up enforcement efforts against companies selling homeopathic products. Since 1988, FDA's enforcement decisions have been made within the framework of Compliance Policy Guide (CPG) § 400.400. Under this policy, the agency generally limited enforcement actions to products that were either inappropriately labeled or manufactured in violation of good manufacturing practice (GMP) regulations. Publication of the new draft guidance document, which officially withdraws CPG 400.400, is the latest signal that the regulatory landscape is changing - perhaps dramatically.
The agency first revealed a new attitude toward homeopathic drugs with the issuance of a draft guidance in December 2017, which laid out a new "risk-based" model of enforcement that would guide agency decisions on homeopathic products. As we previously reported, this effectively rolled back the permissive framework of the CPG, although the agency noted that the CPG would not be withdrawn until the draft guidance is finalized. Not surprisingly, the homeopathic industry pushed back. One group (Americans for Homeopathy Choice) filed a petition urging the retention of the Compliance Policy Guide and the preservation of FDA's pre-guidance homeopathy framework.
Industry efforts do not appear to have worked. The FDA denied the petition of Americans for Homeopathy Choice and, over the first half of 2019, issued several Warning Letters to manufacturers and marketers of homeopathic drug products.1 The 2019 draft guidance document on homeopathy enforcement is nearly identical to the 2017 draft. It sets forth six categories of homeopathic products that reflect the agency's enforcement priorities:
- Products with reports of injury that, after evaluation, raise potential safety concerns
- Products that contain or purport to contain ingredients associated with potentially significant safety concerns
- Products for routes of administration other than oral and topical (e.g., ophthalmic or injectable)
- Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases or conditions
- Products for vulnerable populations (e.g., children, the elderly, pregnant women, or immunocompromised individuals)
- Products with significant quality issues
These categories largely track their 2017 predecessors, but FDA's inclusion of broader categories for products with reports of injuries that raise potential safety concerns (versus products with only reported safety concerns) and for products with significant quality issues (versus adulterated products) underscores the possibility of wider-reaching FDA enforcement actions against manufacturers and marketers.
While the FDA is sending a clear message to the homeopathic industry, we wonder whether the implications could reach beyond regulatory enforcement. By explicitly reaffirming that homeopathic drug products do not have any special status under federal law, the agency is essentially saying that all homeopathic drug products that are not marketed under an approved new drug application (i.e., all homeopathic drug products) are unlawful. This could embolden the plaintiff bar to initiate lawsuits against all companies selling homeopathic products – even those that survive the increased scrutiny of this new FDA enforcement policy. This is just another reason why companies manufacturing, marketing, and/or distributing homeopathic products would be wise not only to reevaluate their quality system, ingredients, and claims to mitigate the risk of being the subject of FDA's next press release, and but also to prepare for the possibility of civil litigation.
There is certainly more to come.